To mark International Clinical Trials Day, celebrated on 20 May, we present three exciting new clinical trials on spinal stenosis, gout and thumb OA.
Three clinical trials that caught the editor’s eye.
Does spinal decompression surgery really work for spinal stenosis?
Decompressive spinal surgery is the most popular treatment for spinal stenosis and involves removing bone and ligament pressing on nerves in the spinal cord and causing pain. However, it’s often carried out on the basis of clinical experience, expert consensus and pathophysiological considerations rather than high quality clinical trial evidence, and its safety and efficacy beyond placebo effects hasn’t been proven.
The SUrgery for Spinal Stenosis (SUcceSS) trial aims to provide clinical trial evidence for decompressive spinal surgery. The trial is led by Professor Manuela Ferreira of the Institute of Bone and Joint Research at the University of Sydney. It is being conducted at five hospitals in Sydney and two in Melbourne, and is currently recruiting.
Participants will be randomly allocated to a surgery placebo group, where patients have a general anaesthetic and an incision in the skin and muscles, or the treatment group that receives decompressive surgery – either laminectomy or laminotomy, as appropriate. The primary outcome is improvement in walking capacity as rated by the patient at three months, and will be reassessed every three months for 24 months.
“The results will provide definitive evidence about the true effect of decompressive surgery and have immediate impact on practice and policy,” said Professor Ferreira.
“If surgery is shown to be superior to placebo, and the benefits outweigh harms, there is strong reason for its endorsement. If superiority is not demonstrated however, it offers strong argument for stopping or reconsidering its use and funding,” she said.
More information see ibjr.sydney.edu.au/volunteer/success
It’s also covered on Poster 56 at the upcoming ARA ASM.
Better outcomes for gout patients
Rheumatologist Dr Helen Keen has been doing some work on barriers to good outcomes in gout and has a number of clinical studies in the pipeline.
One is a clinical trial in collaboration with cardiology professor Girish Dwivedi, assessing the effect of anakinra therapy on cardiovascular risk in acute gout patients.
“We’ve done some work with epidemiological data looking at people with gout admitted to hospital in WA in the last 30 years, and have found those admitted to hospital with gout are more likely to have a heart attack in the months following the admission,” said Dr Keen.
“We think that’s driven by intense inflammation. So, we have a randomised controlled trial looking at addressing that with a really potent anti-inflammatory injection once a day for three days, trying to hit the inflammation on the head. We’ll see if that improves heart outcomes.”
The anti-inflammatory is anti-interleukin-1β biologic anakinra, and will be administered with allopurinol escalation therapy. The control group will receive standard care, which is usual gout management plus allopurinol escalation therapy.
Patients will undergo a coronary CT angiogram at baseline to assess plaque burden in coronary arteries, and this will be repeated at 9 months. Patients will also have monthly assessments including questionnaires, swollen and tender joint count and blood tests.
Primary outcomes include high-risk rupture prone plaque burden and non-calcified coronary plaque burden as determined by CT angiogram.
The trial is being conducted at Fiona Stanley Hospital in Perth is currently recruiting.
Contact Dr Kylan Pathmanathan on 08 61522222 or kylan.pathmanathan@health.wa.gov.au for more information.
Intra-articular hyaluronic acid for thumb osteoarthritis
Basal thumb osteoarthritis is a painful and debilitating condition predominantly affecting older women. There are few proven treatment options, the main ones being conservative treatments (education, exercises, splinting and NSAIDs) and surgery.
Corticosteroid injections are another treatment option, but last only three months. Meanwhile, hyaluronic acid has proven successful in treating other joints, but requires multiple injections which increases the risk of joint infection.
Plastic surgeons Professor Warren Rozen and Professor David Hunter-Smith, clinical professors at Monash University, are trialling intra-articular injections of a new stabilised hyaluronic acid. The compound lasts longer than previous forms of hyaluronic acid and requires only one injection rather than several. It has been found successful in other joints. Controls will be methylprednisolone (active comparator) and saline (placebo) injections.
Primary outcomes are change in pain of affected hand, as measured by the Visual Analogue Scale, Patient Global Assessment score measuring function, pain and disability and Functional Index of Hand Osteoarthritis (FIHOA) score. These will be measured for up to six months.
The phase IV trial is currently in the pre-recruitment phase and is due to start in the coming weeks.
“If successful,” said Professor Rozen, “this could lead to an improvement of pain and function in a significant percentage of the ageing population. It may ultimately lead to PBS approval which would allow Australian patients better access to this medication.”
For more information contact research lead Dr Roger Sachs: roger.sachs@monash.edu
This article was updated to note the collaboration of Professor Girish Dwivedi in the gout-anakinra trial.
